Optetrak Logic 02-012-44-1013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862173416), received between Jun 8, 2022 and Sep 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4) LONG FORM IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 76 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEARPAIN, DISCOMFORT, GAIT IMPAIRMENT, BONE LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6) LOGIC TIBIA IMPLANT PSC SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K110547.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 20189100 ↗
• InjuryNov 13, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2012. THE PATIENT WAS DIAGNOSED WITH MODERATELY SEVERE POLYMERIC-INDUCED SYNOVITIS WITH SEVERE FEMORAL OSTEOLYSIS AND MORE FOCAL TIBIAL OSTEOLYSIS, SYNOVIAL EXPANSION INTO THE GUTTERS EFFACES THE COLLATERAL LIGAMENTS. UNUNITED BONY FRAGMENTS WERE IDENTIFIED ADJACENT TO THE MCL. APPROXIMATELY 10 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2022 DUE TO POLYMERIC-INDUCED SYNOVITIS. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Osteolysis; Pain; Synovitis

  MAUDE report 18120162 ↗
• InjuryJun 8, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL LEFT TKA, THE 66 Y/O FEMALE PATIENT HAD A REVISION. PATIENT WAS COMPLAINING SINCE 6 MONTHS OF ORIGINAL TKA OF PAIN, SWELLING AND DISCOMFORT. PATIENT HAD LITTLE INFLAMMATORY SYNDROME BUT PRESENCE OF GRANULUM. THE PE IS HEAVILY WORN BEHIND THE POSTERIOR CAM AND IN THE ANGLE OF THE EXTERNAL FEMORAL CONDYLE. ONLY PATIENT'S INSERT HAS BEEN REPLACED. X-RAYS AND PHOTOS RECEIVED. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 14632498 ↗